Cleared Traditional

K051440 - MAYFIELD INFINITY SKULL CLAMP

K051440 is an FDA 510(k) clearance for MAYFIELD INFINITY SKULL CLAMP, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K051440 · Integra Lifesciences Corp. · Neurology device
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Sep 2005
Decision
110d
Days
Class 2
Risk

K051440 is an FDA 510(k) clearance for the MAYFIELD INFINITY SKULL CLAMP. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on September 20, 2005 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

FDA 510(k) Submission Details - K051440

510(k) Number K051440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date September 20, 2005
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 38
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K051440.
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · Integra LifeSciences Corporation · Nov 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · Integra Lifesciences Corp. · Mar 2005
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · Image-Guided Neurologics, Inc. · Aug 2003
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · Ohio Medical Instrument Co., Inc. · Jul 2002